We conducted a prospective, randomized, controlled trial to assess whe
ther hospital formulary restrictions involving limiting dosage strengt
hs of levothyroxine affect physicians' ability to manage patients effe
ctively and provide pharmacy cost savings in a tertiary care federal g
overnment research hospital. Thirty-three endocrinologists were random
ly assigned to prescribe levothyroxine from a restrictive (dosage stre
ngths of 25, 50, 100, 125, and 150 mu g) or a nonrestrictive (dosage s
trengths of 25, 50, 75, 100, 112, 125, 150, 175, 200, and 300 mu g) fo
rmulary through a central computer system. Their 241 respective outpat
ients' laboratory results and drug compliance were outcome measures. A
chievement of treatment objectives was measured by thyroid function te
sts (free and total thyroxine, total triiodothyronine, thyrotropin), n
umber of clinic visits, and compliance (survey method). Additional mea
sures were drug distribution patterns, drug costs, and pharmacy invent
ory costs. Restriction of levothyroxine's dosage strength did not sign
ificantly alter therapeutic outcomes. However, the restricted formular
y was associated with more complex dosing regimens, and resulted in no
significant cost savings. It is not known whether such restriction wo
uld adversely affect the care of patients of nonspecialists. Prospecti
ve studies are required to verify presumed cost-containment measures b
efore such measures are adopted for widespread application.